1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01191216|
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : July 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: 1-methyl-d-tryptophan Drug: docetaxel Other: diagnostic laboratory biomarker analysis Other: pharmacological study||Phase 1|
I. The MTD of the 1-MT/docetaxel combination using CTCAE 4.0 criteria.
I. Determination of PK data for the combination of docetaxel plus oral 1-MT.Overall objective response rate (CR, PR) per RECIST criteria.
OUTLINE: This is a dose-escalation study.
Patients receive oral 1-methyl-d-tryptophan twice daily on days 1-21 and docetaxel IV over 1 hour on day 1 (in course one patients receive 1-methyl-d-tryptophan once daily on days 1 and 3-21). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic and correlative studies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of 1-Methyl-D-tryptophan (NSC-721782) in Combination With Docetaxel in Metastatic Solid Tumors|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Arm I
Patients receive oral 1-methyl-d-tryptophan twice daily on days 1-21 and docetaxel IV over 1 hour on day 1 (in course one patients receive 1-methyl-d-tryptophan once daily on days 1 and 3-21).
Other Name: indoximod
Other: diagnostic laboratory biomarker analysis
Other: pharmacological study
Other Name: pharmacological studies
- MTD defined as the dose level in which 1 of 6 patients experiences DLT assessed using CTCAE version 4.0 [ Time Frame: 21 days ]
- PK data [ Time Frame: 0, 1, 2, 4, 8, 12, 24, and 48 hours ]
- Overall objective response rate per RECIST criteria [ Time Frame: From the start of the treatment until disease progression/recurrence ]The analysis will be descriptive in nature as it will include patients with metastatic solid tumors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191216
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Montana|
|Billings, Montana, United States, 59107-7000|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Hatem Soliman||H. Lee Moffitt Cancer Center and Research Institute|